FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
75721–75744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2002
DAVLITE MICROENDOSCOPE & ACCESSORIES
K020310 · GCJ
Davlite Technologies
General & Plastic Surgery · 50d
Cleared Mar 20, 2002
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC...
K020316 · DQO
Cordis Corp.
Cardiovascular · 49d
Cleared Mar 20, 2002
PASCO MIC AND MIC/ID PANELS
K020331 · JWY
Pasco Laboratories, Inc.
Microbiology · 48d
Cleared Mar 20, 2002
BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757
K020523 · SCL
Bd
General Hospital · 29d
Cleared Mar 20, 2002
PATIENTNET MONITORING SYSTEM
K020524 · MSX
General Electric Medical Systems...
Cardiovascular · 29d
Cleared Mar 20, 2002
PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A
K020531 · MHX
Philips Medical Systems
Cardiovascular · 29d
Cleared Mar 20, 2002
MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER
K020590 · FLE
Getinge/Castle, Inc.
General Hospital · 26d
Cleared Mar 20, 2002
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
K020660 · MEB
I-Flow Corp.
General Hospital · 19d
Cleared Mar 20, 2002
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
K020777 · MNS
Respironics, Inc.
Anesthesiology · 9d
Cleared Mar 19, 2002
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01
K010253 · DYG
Transonic Systems, Inc.
Cardiovascular · 417d
Cleared Mar 19, 2002
HEARTTRENDS
K012825 · DQK
Lev-El, Ltd.
Cardiovascular · 208d
Cleared Mar 19, 2002
INCARE PELVIC FLOOR THERAPY SYSTEM
K013612 · HIR
Hollister, Inc.
Gastroenterology & Urology · 134d
Cleared Mar 19, 2002
NELSON ELECTROSURGICAL UNIT, MODEL GN640
K014172 · GEI
Aesculap, Inc.
General & Plastic Surgery · 89d
Cleared Mar 19, 2002
KAYAK HYDROPHILIC GUIDE WIRES
K014195 · DOX
Boston Scientific Corp
Toxicology · 88d
Cleared Mar 19, 2002
SULZER DENTAL CERAMIC SYSTEM-SPLINE
K014214 · DZE
Sulzer Dental, Inc.
Dental · 88d
Cleared Mar 19, 2002
IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3
K020237 · JJY
Consolidated Technology
Chemistry · 55d
Cleared Mar 19, 2002
UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
K020500 · SCL
Univec, Inc.
General Hospital · 33d
Cleared Mar 19, 2002
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
K020526 · FHN
Don Wilson/Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 18, 2002
CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR
K013201 · GEX
Cardiofocus, Inc.
General & Plastic Surgery · 174d
Cleared Mar 18, 2002
PAEDISCOPE, MODEL # P010A AND PF011A
K014149 · GWG
Aesculap, Inc.
Neurology · 90d
Cleared Mar 18, 2002
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09
K014154 · HWC
Vilex, Inc.
Orthopedic · 90d
Cleared Mar 18, 2002
OPENING/CLOSING WEDGE OSTETOMY PLATES
K014155 · HRS
Arthrex, Inc.
Orthopedic · 89d
Cleared Mar 18, 2002
CERASORB ORTHO
K014156 · MQV
Curasan AG
Orthopedic · 89d
Cleared Mar 18, 2002
FORTAFLEX SURGICAL MESH
K020049 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 70d